Events

Recall of Device Recall XiO Radiation Treatment Planning System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Computerized Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55008
  • Event Risk Class
    Class 2
  • Event Number
    Z-1209-2010
  • Event Initiated Date
    2010-02-22
  • Event Date Posted
    2010-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89670
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Inconsistent mlc positions, dose, and monitor units.
  • Action
    Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.

Device

Device Recall XiO Radiation Treatment Planning System
  • Model / Serial
    Release 4.51.00
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
  • Product Description
    XiO Radiation Treatment Planning System, Release 4.51.00.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Manufacturer Address
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA